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5-FU CVC product candidate receive FDA marketing clearance, we would
anticipate commencing commercial launch activities in the second half
of 2008.
- Quill(TM) SRS: In October 2007 we received CE Mark approval to begin
marketing the Quill(TM) Self-Retaining System (SRS) MONODERM(TM)
product line in Europe. In addition, we exceeded our stated goal of
100 Quill(TM) SRS hospital accounts by the end of 2007, and expect to
expand the number of Quill(TM) SRS SKUs available for sale to our
customers in 2008.
- Vascular Wrap(TM): Enrolment in our AV access human clinical trials
in the U.S. and Europe continues and we currently expect to complete
enrolment in these studies around the end of the first half of 2008.
- Stem Cell Therapies: In December 2007 our partner, Athersys, Inc.
received authorization from the U.S. FDA to begin a Phase I clinical
trial evaluating the safety of MultiStem(R) in the treatment of acute
myocardial infarction. We have an agreement with Athersys to co-
develop and commercialize MultiStem(R), Athersys' non-embryonic stem
cell platform technology, for use in the indications of acute
myocardial infarction and peripheral vascular disease.
- TAXUS(R) paclitaxel-eluting stent systems: In December 2007 our
partner, BSC, announced that the TAXUS(R) Liberte(TM) paclitaxel-
eluting coronary stent system received European CE Mark approval for
use in diabetic patients.
2008 Outlook
Our financial outlook for the upcoming fiscal year ending December 31,
2008 is presented below. Several material factors and assumptions were used
to derive our 2008 outlook, including: (i) estimates of medical procedure
and patient population growth rates for the various end markets relating
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